- General information enquiries
- Call 00 800 6 7 8 9 10 11
- E-mail your questions
Directorate-General for Health and Food Safety
1. Adoption of the Agenda (doc. n° SCCNFP/0093/98)
(Annex 1)
The agenda was adopted.
2. Approval of the minutes of the 5th plenary meeting of 25 November 1998
doc. n° SCCNFP/0086/98
The minutes were adopted subject to the some orthographic corrections.
In the margin of the adoption of these minutes, the chairman mentioned that (i) the human volunteers/tests on humans in all its aspects will be a major and sensible item the committee has to deal with in framework of its discussions concerning alternative methods and that (ii) a task force on hair dyes has been set up. The TF will meet for the first time from 1 to 4 February and will go, in the first place, through all the 32 priority files identified by the WP 'Hair Dyes' and will write a status report on each of them.
3. Alternatives to Animal Testing
3.1 Report of the Co-ordinator
This plenary meeting was in particular organised to discuss and conclude on the state of the art of the alternative methods to animal testing in the safety evaluation of cosmetic ingredients or mixtures of ingredients. The SCCNFP was asked by the Commission, in the framework of Council Directive 76/768/EEC on cosmetic products, to review the status of alternative methods and provide her with a report by the end of January 1999.
A series of meetings were organised during which matters were discussed with representatives of DG III, DG XI, DG XII, ECVAM as well as with representatives of the European Cosmetic Industry.
As a result, a status report was prepared by the WP 'Alternatives' and presented to the Plenary for adoption.
The co-ordinator said that the committee's work for this meeting consisted of :
* the adoption of the in vitro methods to assess percutaneous absorption of cosmetic ingredients;
* the adoption of the status report on alternatives;
* the revision of the Notes of Guidance, and
* the establishment of a work programme for 99.
3.2 Draft opinion on in vitro assessment of percutaneous absorption of cosmetic ingredients, doc. n° SCCNFP/0088/98
The document is the result of work started in 1995 when the cosmetic industry presented to the former SCC an industrial view on in vitro assessment of percutaneous absorption of cosmetic ingredients. The SCC emphasised that the test protocols used by industry were not subjected to a formal validation test and recommended that the existing documentation should be supplemented by intra- and inter-laboratory reproducibility data, data on the influence of the vehicle on the release of the cosmetic ingredients and other technical and experimental details.
Nevertheless, the former SCC was and the present SCCNFP is convinced of the relevance of in vitro methods and has since recent years agreed to consider in vitro percutaneous absorption data in the evaluation of the safety of cosmetic ingredients, where applicable.
New documentation of the subject was received and consequently evaluated. The data reported indicate the potential usefulness of the in vitro methodologies. However the data provided at this moment are not sufficient enough to formulate a scientific opinion on how to conduct reliable in vitro percutaneous absorption studies and assess the results. Moreover, minimal requirements needed for the acceptance of in vitro percutaneous absorption studies, based on scientific literature and on the experience of the SCCNFP, should be formulated and agreed upon by the parties concerned.
As a general remark, the committee concluded that studies to standardise methodologies for in vitro percutaneous absorption for cosmetic ingredients are necessary and should be shown to be reproducible and relevant. Moreover, it was recommended that independent research institutes should perform or co-ordinate this work.
Subject to typographical corrections, the paper was adopted by the plenary meeting.
3.3 Formal opinion of the state of the art, doc. n° SCCNFP/0103/99
With reference to what is said under point 3.1 Report of the Co-ordinator, the committee was asked to review the status of alternative methods to animal testing in the safety evaluation of cosmetic ingredients and to make their conclusions available by the end of January 1999.
Three areas were considered, namely skin corrosivity, photo-toxicity and percutaneous absorption. The applicability to the cosmetic sector of the in vitro methods developed in these areas was reviewed and evaluated.
As a consequence, the committee adopted opinions on the following methods :
* In vitro methods to assess skin corrosivity in the safety evaluation of cosmetic ingredients or mixtures of ingredients;
* In vitro methods to assess photo-toxicity in the safety evaluation of cosmetic ingredients or mixtures of ingredients;
* In vitro methods to assess percutaneous absorption of cosmetic ingredients.
In the state of the art, the SCCNFP concludes that the three in vitro methods to assess skin corrosivity (TER test and EPISKIN test) and to assess photo-toxicity (3T3 NRU PT) have been validated and can be considered to be applicable to the safety evaluation of cosmetic ingredients or mixtures of ingredients.
Moreover, the SCCNFP has considered the possible usefulness of the various existing in vitro methodologies to evaluate the percutaneous absorption of cosmetic ingredients and will define a set of minimal criteria needed for the acceptance of in vitro percutaneous absorption studies for the evaluation of the toxicological profile of cosmetic ingredients.
Scientists performing such tests are requested, besides describing the respective test in detail, to elucidate also the scientific background for their choice of the used methodology, including hints to the literature.
3.4 Update of the second revision of the SCC's Notes of Guidance
In its report on the status of alternative methods, the committee mentioned as well the updating of the 2nd revision of the Notes of Guidance for Testing of Cosmetic Ingredients for their Safety Evaluation.
In 1998, the committee adopted (i) guidelines on the use of human volunteers in the testing of potentially cutaneous irritant cosmetic ingredients or mixtures of ingredients and (ii) a revised Annex 7 of the Notes of Guidance concerning the microbiological quality of the finished cosmetic product. These two issue will be included in the updated version of the Notes with corresponding chapters in the main text of the document.
3.5 Work programme 99
The third chapter the status report deals with the work programme for 1999 and is based on the request received so far from the Commission. The programme consists, at present, of the following issues :
* Present development and validation of adequate alternative methodologies to the use of animals in the safety testing in cosmetics.
* Eye irritation: possible strategies for using validated in vitro methods for selected classes of cosmetic ingredients.
* Minimal Criteria of the in vitro test protocols for assessing percutaneous absorption of cosmetic ingredients;
* Minimal Criteria of the protocols for the testing of potentially cutaneous irritant cosmetic ingredients or mixtures of ingredients on human volunteers;
* Levels of exposure of consumers to cosmetic ingredients and finished cosmetic products. Revision of Annex 4 of document XXIV/1878/97;
* Guidelines on the use of human volunteers in the testing of finished cosmetic products;
* Guidelines on the use of human volunteers in the testing of potentially cutaneous sensitizing cosmetic ingredients or mixtures of ingredients;
4 Report of the Chairman
* Diethylphthalate : the committee was asked not only to review the use of diethylphthalate in cosmetic products but also to consider its 'non-food' applications.
However, it was said to evaluate in the first place only its use in cosmetics and to postpone the non-food part to a later date.
The secretariat was asked to request from COLIPA specific data on the use of the substance in cosmetic formulations.
* WP 'Absorption' : when evaluating the safety of ingredients, the committee is asking itself to what extend oral sub-chronic toxicity data can be extrapolated to a dermal application. To answer this question, a Working Party 'Absorption' was established which should look into this issue.
5. Any Other Business
* Expert panel workshop to address health risks and health protection in relation to exposure to the sun : the chairman said that the workshop is postponed to later this year due to a longer preparatory phase.
Attendance List
Present : Mr K.E. Andersen, Mr R. Anton, Mr J-F. Doré, Mr V. Kapoulas, Mr F. Kemper, Mr B. Lina, Mr N. Loprieno, Mr J. Parra Mr C.J. Powell, Mrs V. Rogiers, Mr T. Sanner, Mr J. Vives Rego, Mr I. White
Commission : Mr L. Bansil DG III, Mrs P. Decamps DG XXIV, Mrs M. de Solà DG XXIV, Mrs F. Drion DG XXIV, Mr G. Fracchia DG XII, Mr D. Rothammer DG XXIV, Mr A. Van Elst DG XXIV
Apologies : Mr P. Blain, Mrs Y. De Roeck-Holtzhauer, Mr. P. Elsner
Agenda for the 6th plenary meeting (Brussels, 20 January 1999)
1. Adoption of the agenda SCCNFP/0093/98
2. Approval of the minutes of the 5th plenary meeting of 25.11.98 SCCNFP/0086/98
3. Alternatives to Animal Testing
3.1 Report of the Co-ordinator
3.2 Draft opinion on in vitro assessment of percutaneous absorption of cosmetic ingredients SCCNFP/0088/98
3.3 Formal opinion of state of the art
rapporteur : Prof. Loprieno
3.4 Update of the second revision of the SCC's Notes of Guidance
rapporteur : Prof. Loprieno
3.5 Work programme 99 :
* in vitro assessment of eye irritation
* definition of general criteria for human testing
* guidance on the use of human volunteers for the testing of finished products
4. Report of the Chairman
5. Any other business
Annex I
Mandate to the SCCNFP (doc. n° XXIV/1890/98)
1. The SCCNFP shall act as a resource of scientific expertise to the European Commission, with regards to, among others, the development of alternative methods. To that effect regularly meeting are foreseen with representatives from the concerned parties to :
give pro-active advice on research proposals and on-going studies
offer, as appropriate, peer reviews of study data.
However, such advice in no way prejudices the right of the SCCNFP to reject data previously discussed, if the scientific standard of the work is considered inappropriate.
Þ The SCCNFP shall serve as an expert resource, as appropriate, to those services of the Commission charged with the validation of alternative methods. Specifically, they should offer expert guidance in the design and applicability of test methods, the selection of test materials and communication of results as they apply to cosmetic products.
Þ The SCCNFP shall, on the request of the appropriate Commission services, review data submitted on in vitro methods that have been assessed and validated by the services of the European Commission, or could be considered appropriate for the replacement of methods using animal testing. The SCCNFP shall give an opinion, and offer guidance as appropriate, on the applicability of such tests in the evaluation of the safety of cosmetic ingredients and products.
Þ The SCCNFP should encourage the use of appropriate in vitro methods for use in the safety evaluation of cosmetic ingredients and products. To this end, it shall consider data from in vitro tests that are submitted in support of safety dossiers from the Industry, if the scientific design, justification and data presentation of such studies are considered of an acceptable scientific standard.
Þ Upon request, the SCCNFP shall advice the European Commission on the status of alternatives to animal testing in cosmetics on an on-going basis and in particularly, in accordance with Article 4, 1(1) of the EU Cosmetic Directive 76/768/EEC.
Although this mandate has been developed in relation to cosmetic ingredients, it is envisaged that scientifically sound non-animal methods for safety assessment will have broad application.
2. The SCCNFP was requested to continuously update the Notes of Guidance for Testing of Cosmetic Ingredients for their Safety Evaluation as stated on page 8 of the 2nd Revision, adopted by the former SCC (Scientific Committee on Cosmetology) on January 16th, 1997.
Due to the almost complete review of the former SCC, and the presence in the SCCNFP of experts on other disciplines, it was decided to include technical modifications to the content of the Notes, such as Guidelines for Human Testing, as it seems appropriate to give advice on this new aspects.
The agenda was adopted.
2. Approval of the minutes of the 5th plenary meeting of 25 November 1998
doc. n° SCCNFP/0086/98
The minutes were adopted subject to the some orthographic corrections.
In the margin of the adoption of these minutes, the chairman mentioned that (i) the human volunteers/tests on humans in all its aspects will be a major and sensible item the committee has to deal with in framework of its discussions concerning alternative methods and that (ii) a task force on hair dyes has been set up. The TF will meet for the first time from 1 to 4 February and will go, in the first place, through all the 32 priority files identified by the WP 'Hair Dyes' and will write a status report on each of them.
3. Alternatives to Animal Testing
3.1 Report of the Co-ordinator
This plenary meeting was in particular organised to discuss and conclude on the state of the art of the alternative methods to animal testing in the safety evaluation of cosmetic ingredients or mixtures of ingredients. The SCCNFP was asked by the Commission, in the framework of Council Directive 76/768/EEC on cosmetic products, to review the status of alternative methods and provide her with a report by the end of January 1999.
A series of meetings were organised during which matters were discussed with representatives of DG III, DG XI, DG XII, ECVAM as well as with representatives of the European Cosmetic Industry.
As a result, a status report was prepared by the WP 'Alternatives' and presented to the Plenary for adoption.
The co-ordinator said that the committee's work for this meeting consisted of :
* the adoption of the in vitro methods to assess percutaneous absorption of cosmetic ingredients;
* the adoption of the status report on alternatives;
* the revision of the Notes of Guidance, and
* the establishment of a work programme for 99.
3.2 Draft opinion on in vitro assessment of percutaneous absorption of cosmetic ingredients, doc. n° SCCNFP/0088/98
The document is the result of work started in 1995 when the cosmetic industry presented to the former SCC an industrial view on in vitro assessment of percutaneous absorption of cosmetic ingredients. The SCC emphasised that the test protocols used by industry were not subjected to a formal validation test and recommended that the existing documentation should be supplemented by intra- and inter-laboratory reproducibility data, data on the influence of the vehicle on the release of the cosmetic ingredients and other technical and experimental details.
Nevertheless, the former SCC was and the present SCCNFP is convinced of the relevance of in vitro methods and has since recent years agreed to consider in vitro percutaneous absorption data in the evaluation of the safety of cosmetic ingredients, where applicable.
New documentation of the subject was received and consequently evaluated. The data reported indicate the potential usefulness of the in vitro methodologies. However the data provided at this moment are not sufficient enough to formulate a scientific opinion on how to conduct reliable in vitro percutaneous absorption studies and assess the results. Moreover, minimal requirements needed for the acceptance of in vitro percutaneous absorption studies, based on scientific literature and on the experience of the SCCNFP, should be formulated and agreed upon by the parties concerned.
As a general remark, the committee concluded that studies to standardise methodologies for in vitro percutaneous absorption for cosmetic ingredients are necessary and should be shown to be reproducible and relevant. Moreover, it was recommended that independent research institutes should perform or co-ordinate this work.
Subject to typographical corrections, the paper was adopted by the plenary meeting.
3.3 Formal opinion of the state of the art, doc. n° SCCNFP/0103/99
With reference to what is said under point 3.1 Report of the Co-ordinator, the committee was asked to review the status of alternative methods to animal testing in the safety evaluation of cosmetic ingredients and to make their conclusions available by the end of January 1999.
Three areas were considered, namely skin corrosivity, photo-toxicity and percutaneous absorption. The applicability to the cosmetic sector of the in vitro methods developed in these areas was reviewed and evaluated.
As a consequence, the committee adopted opinions on the following methods :
* In vitro methods to assess skin corrosivity in the safety evaluation of cosmetic ingredients or mixtures of ingredients;
* In vitro methods to assess photo-toxicity in the safety evaluation of cosmetic ingredients or mixtures of ingredients;
* In vitro methods to assess percutaneous absorption of cosmetic ingredients.
In the state of the art, the SCCNFP concludes that the three in vitro methods to assess skin corrosivity (TER test and EPISKIN test) and to assess photo-toxicity (3T3 NRU PT) have been validated and can be considered to be applicable to the safety evaluation of cosmetic ingredients or mixtures of ingredients.
Moreover, the SCCNFP has considered the possible usefulness of the various existing in vitro methodologies to evaluate the percutaneous absorption of cosmetic ingredients and will define a set of minimal criteria needed for the acceptance of in vitro percutaneous absorption studies for the evaluation of the toxicological profile of cosmetic ingredients.
Scientists performing such tests are requested, besides describing the respective test in detail, to elucidate also the scientific background for their choice of the used methodology, including hints to the literature.
3.4 Update of the second revision of the SCC's Notes of Guidance
In its report on the status of alternative methods, the committee mentioned as well the updating of the 2nd revision of the Notes of Guidance for Testing of Cosmetic Ingredients for their Safety Evaluation.
In 1998, the committee adopted (i) guidelines on the use of human volunteers in the testing of potentially cutaneous irritant cosmetic ingredients or mixtures of ingredients and (ii) a revised Annex 7 of the Notes of Guidance concerning the microbiological quality of the finished cosmetic product. These two issue will be included in the updated version of the Notes with corresponding chapters in the main text of the document.
3.5 Work programme 99
The third chapter the status report deals with the work programme for 1999 and is based on the request received so far from the Commission. The programme consists, at present, of the following issues :
* Present development and validation of adequate alternative methodologies to the use of animals in the safety testing in cosmetics.
* Eye irritation: possible strategies for using validated in vitro methods for selected classes of cosmetic ingredients.
* Minimal Criteria of the in vitro test protocols for assessing percutaneous absorption of cosmetic ingredients;
* Minimal Criteria of the protocols for the testing of potentially cutaneous irritant cosmetic ingredients or mixtures of ingredients on human volunteers;
* Levels of exposure of consumers to cosmetic ingredients and finished cosmetic products. Revision of Annex 4 of document XXIV/1878/97;
* Guidelines on the use of human volunteers in the testing of finished cosmetic products;
* Guidelines on the use of human volunteers in the testing of potentially cutaneous sensitizing cosmetic ingredients or mixtures of ingredients;
4 Report of the Chairman
* Diethylphthalate : the committee was asked not only to review the use of diethylphthalate in cosmetic products but also to consider its 'non-food' applications.
However, it was said to evaluate in the first place only its use in cosmetics and to postpone the non-food part to a later date.
The secretariat was asked to request from COLIPA specific data on the use of the substance in cosmetic formulations.
* WP 'Absorption' : when evaluating the safety of ingredients, the committee is asking itself to what extend oral sub-chronic toxicity data can be extrapolated to a dermal application. To answer this question, a Working Party 'Absorption' was established which should look into this issue.
5. Any Other Business
* Expert panel workshop to address health risks and health protection in relation to exposure to the sun : the chairman said that the workshop is postponed to later this year due to a longer preparatory phase.
Attendance List
Present : Mr K.E. Andersen, Mr R. Anton, Mr J-F. Doré, Mr V. Kapoulas, Mr F. Kemper, Mr B. Lina, Mr N. Loprieno, Mr J. Parra Mr C.J. Powell, Mrs V. Rogiers, Mr T. Sanner, Mr J. Vives Rego, Mr I. White
Commission : Mr L. Bansil DG III, Mrs P. Decamps DG XXIV, Mrs M. de Solà DG XXIV, Mrs F. Drion DG XXIV, Mr G. Fracchia DG XII, Mr D. Rothammer DG XXIV, Mr A. Van Elst DG XXIV
Apologies : Mr P. Blain, Mrs Y. De Roeck-Holtzhauer, Mr. P. Elsner
Agenda for the 6th plenary meeting (Brussels, 20 January 1999)
1. Adoption of the agenda SCCNFP/0093/98
2. Approval of the minutes of the 5th plenary meeting of 25.11.98 SCCNFP/0086/98
3. Alternatives to Animal Testing
3.1 Report of the Co-ordinator
3.2 Draft opinion on in vitro assessment of percutaneous absorption of cosmetic ingredients SCCNFP/0088/98
3.3 Formal opinion of state of the art
rapporteur : Prof. Loprieno
3.4 Update of the second revision of the SCC's Notes of Guidance
rapporteur : Prof. Loprieno
3.5 Work programme 99 :
* in vitro assessment of eye irritation
* definition of general criteria for human testing
* guidance on the use of human volunteers for the testing of finished products
4. Report of the Chairman
5. Any other business
Annex I
Mandate to the SCCNFP (doc. n° XXIV/1890/98)
1. The SCCNFP shall act as a resource of scientific expertise to the European Commission, with regards to, among others, the development of alternative methods. To that effect regularly meeting are foreseen with representatives from the concerned parties to :
give pro-active advice on research proposals and on-going studies
offer, as appropriate, peer reviews of study data.
However, such advice in no way prejudices the right of the SCCNFP to reject data previously discussed, if the scientific standard of the work is considered inappropriate.
Þ The SCCNFP shall serve as an expert resource, as appropriate, to those services of the Commission charged with the validation of alternative methods. Specifically, they should offer expert guidance in the design and applicability of test methods, the selection of test materials and communication of results as they apply to cosmetic products.
Þ The SCCNFP shall, on the request of the appropriate Commission services, review data submitted on in vitro methods that have been assessed and validated by the services of the European Commission, or could be considered appropriate for the replacement of methods using animal testing. The SCCNFP shall give an opinion, and offer guidance as appropriate, on the applicability of such tests in the evaluation of the safety of cosmetic ingredients and products.
Þ The SCCNFP should encourage the use of appropriate in vitro methods for use in the safety evaluation of cosmetic ingredients and products. To this end, it shall consider data from in vitro tests that are submitted in support of safety dossiers from the Industry, if the scientific design, justification and data presentation of such studies are considered of an acceptable scientific standard.
Þ Upon request, the SCCNFP shall advice the European Commission on the status of alternatives to animal testing in cosmetics on an on-going basis and in particularly, in accordance with Article 4, 1(1) of the EU Cosmetic Directive 76/768/EEC.
Although this mandate has been developed in relation to cosmetic ingredients, it is envisaged that scientifically sound non-animal methods for safety assessment will have broad application.
2. The SCCNFP was requested to continuously update the Notes of Guidance for Testing of Cosmetic Ingredients for their Safety Evaluation as stated on page 8 of the 2nd Revision, adopted by the former SCC (Scientific Committee on Cosmetology) on January 16th, 1997.
Due to the almost complete review of the former SCC, and the presence in the SCCNFP of experts on other disciplines, it was decided to include technical modifications to the content of the Notes, such as Guidelines for Human Testing, as it seems appropriate to give advice on this new aspects.
